Lysteda

Product NDC: 69918-300
11-digit product format: 699180300
Labeler code: 69918
Product ID: 69918-300_25ba7e46-0431-4948-8543-052c26bdabe8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tranexamic Acid
Dosage form: TABLET
Route: ORAL
Labeler: Amring Pharmaceuticals Inc.
Application: NDA022430
Marketing category: NDA
Marketing start: 2010-05-17
Marketing end: 0000-00-00
Substance: TRANEXAMIC ACID
Active strength: 650 mg/1
Pharmacologic classes: Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69918-300		D	Discontinued by firm		2026-08-17
excluded package	package	69918-300	69918-300-30	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69918-300-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69918-300-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69918-300-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69918-300-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69918-300-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69918-300-30	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022430-001	LYSTEDA	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022430-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022430-001	LYSTEDA	650MG	TABLET / ORAL	AB	RLD, RS	2009-11-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022430-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022430-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022430-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022430-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022430-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022430-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022430-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022430-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022430-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022430-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022430-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022430-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022430-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022430-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022430-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022430-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022430-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022430-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022430-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022430-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022430-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022430-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022430-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022430-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022430-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022430-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022430-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022430-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022430-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022430-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022430-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022430-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022430-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022430-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022430-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022430-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 312 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	7947739	2025-03-04		Drug product	2011-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	8022106	2025-03-04	U-1182		2011-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	8273795	2025-03-04	U-1182		2012-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	8487005	2025-03-04	U-1182	Drug product	2013-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	8791160	2025-03-04	U-1182	Drug product	2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	8809394	2025-03-04	U-1182	Drug product	2014-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	8957113	2025-03-04	U-1182	Drug product	2015-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022430-001	9060939	2025-03-04		Drug product	2015-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022430-001	7947739	2025-03-04		Drug product	2011-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022430-001	8022106	2025-03-04	U-1182		2011-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022430-001	8273795	2025-03-04	U-1182		2012-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022430-001	8487005	2025-03-04	U-1182	Drug product	2013-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022430-001	8791160	2025-03-04	U-1182	Drug product	2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022430-001	8809394	2025-03-04	U-1182	Drug product	2014-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022430-001	8957113	2025-03-04	U-1182	Drug product	2015-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022430-001	9060939	2025-03-04		Drug product	2015-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	7947739	2025-03-04		Drug product	2011-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	8022106	2025-03-04	U-1182		2011-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	8273795	2025-03-04	U-1182		2012-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	8487005	2025-03-04	U-1182	Drug product	2013-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	8791160	2025-03-04	U-1182	Drug product	2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	8809394	2025-03-04	U-1182	Drug product	2014-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	8957113	2025-03-04	U-1182	Drug product	2015-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022430-001	9060939	2025-03-04		Drug product	2015-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	7947739	2025-03-04		Drug product	2011-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	8022106	2025-03-04	U-1182		2011-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	8273795	2025-03-04	U-1182		2012-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	8487005	2025-03-04	U-1182	Drug product	2013-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	8791160	2025-03-04	U-1182	Drug product	2014-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	8809394	2025-03-04	U-1182	Drug product	2014-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	8957113	2025-03-04	U-1182	Drug product	2015-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022430-001	9060939	2025-03-04		Drug product	2015-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	7947739	2025-03-04		Drug product	2011-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	8022106	2025-03-04	U-1182		2011-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	8273795	2025-03-04	U-1182		2012-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	8487005	2025-03-04	U-1182	Drug product	2013-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	8791160	2025-03-04	U-1182	Drug product	2014-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	8809394	2025-03-04	U-1182	Drug product	2014-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	8957113	2025-03-04	U-1182	Drug product	2015-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022430-001	9060939	2025-03-04		Drug product	2015-06-23	`03ed91905a0d…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tranexamic Acid	TRANEXAMIC ACID	AvPAK	e8cdb0d6-9498-2902-e053-2995a90a9de4	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022430 application number: NDA022430
Tranexamic Acid	TRANEXAMIC ACID	Nordic Pharma, Inc.	031bf7c2-3b07-469d-bc5a-31fc6238e25f	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022430 application number: NDA022430

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6T84R30KC1	TRANEXAMIC ACID	1197-18-8	TRANEXAMIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69918-300-30	69918030030	30 TABLET in 1 BOTTLE (69918-300-30)	30 tablet	2010-05-17	0000-00-00	No	No	Current